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PET Scan with PF-03654746

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Mar 4, 2019

PET Scan with PF-03654746 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

PET Scan with PF-03654746 clinical trials

PET Scan with PF-03654746 · 1 trial · 1 indication

Phase 1 1
NCT00730990A Phase I, Healthy Volunteer Positron Emission Tomography StudyHealthy
COMPLETED10 Analytics
PHASE1COMPLETED
A Phase I, Healthy Volunteer Positron Emission Tomography Study
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall H3 Receptor Occupancy of PF 03654746.
48 hours

Secondary Endpoints

Binding potential (BP) of [C-11]PF 04621053.
48 hours
Relationship between serum PF 03654746 concentration and H3 RO (IC50).
48 hours
H3 RO of PF 03654746 at regions of interest in man
48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALThis arm will have no active treatment.
Cohort 2EXPERIMENTAL -

Interventions

NameTypeDescription
Positron Emission tomographyOTHERPositron Emission tomography scans. Part 1of the study : 4 subjects will receive 2 scans a day for 1 day with PET ligand administered in tracer quantities.
PET Scan with PF-03654746DRUGIf none of the data from Cohort 2 is informative, then: 2) an additional 3 subjects will receive 2 Scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746. Doses will be determined based upon the outcome of the first intervention.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical l...

Countries:United States
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Frequently asked questions about PET Scan with PF-03654746

What is PET Scan with PF-03654746?

PET Scan with PF-03654746 is a Phase 1 positron emission tomography imaging approach that uses the small molecule PF-03654746 as a radiotracer to visualize its distribution in the body. It was studied in healthy male volunteers in the United States. The study is completed and no indication has been disclosed.

Who is developing PET Scan with PF-03654746?

PET Scan with PF-03654746 is being developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 healthy volunteer PET imaging study of this small molecule tracer.

What phase is PET Scan with PF-03654746 in?

PET Scan with PF-03654746 is in Phase 1 development. The only listed trial is a completed Phase 1 positron emission tomography study in healthy volunteers. It is investigational and has not been approved for any use.

What clinical trials is PET Scan with PF-03654746 in?

PET Scan with PF-03654746 has been studied in one clinical trial, NCT00730990, titled A Phase I, Healthy Volunteer Positron Emission Tomography Study. It was a completed Phase 1 trial with 10 enrolled participants, conducted in the United States.

What is PET Scan with PF-03654746 used for?

PET Scan with PF-03654746 is used as a positron emission tomography imaging agent in research settings. The Phase 1 trial evaluated it in healthy male volunteers aged 18 years and older. No therapeutic indication has been disclosed for this imaging approach.